Arrangement for the Removal of Waste Products During the Ablation of Biological Tissue

ABSTRACT

The invention relates to an arrangement for the removal of waste products, such as smoke and tissue particles, arising during the ablation of biological tissue by means of laser irradiation. According to the invention, discharge openings for a flushing gas are provided, which are arranged such that the gas flows meet above the ablation region at an angle of ca. 100° and stratify to give a gas flow taken up by a suction opening.

The invention refers to a device for removing residual products, such as smoke and tissue particles, which develop during the ablation of biological tissue by laser radiation.

It is well-known that biological tissue can be ablated by bringing in laser energy without substantial thermal damage of the target areas. This quasi non-thermal process is used for example in medicine for the treatment of cartilage, dental hard tissue, skin areas and also during eye surgery for forming the cornea (Photorefractive keratectomy, PRK). Such procedures and the associated device have been published for example in patents DE 197 27 573 C1 and EP 0 412 789 B1. A further procedure, in which the cornea is worked on by means of lasers, is the in-situ laser keratomileusis (LASIK). In contrast with PRK, a cut is first made here into the cornea and a so-called “flap” is produced, which is folded away during the laser procedure in the work area. After concluding the ablation, which takes place thereby quasi in the cornea inside, the flap is again folded back.

It is unfavorable that the residual products resulting from the tissue developing from the tissue ablation affects the air quality in direct proximity of the treatment place in the form of smoke or tissue particles, which leads on one hand to the smelling nuisance for the patient and the treating personnel, and on the other hand that the laser radiation is partially weakened. The latter has a particular relevance in the photorefractive keratectomy, with which the cornea surface is formed by a precise material removal. This depends besides from an unhindered, sensitive orientation of the laser beam, also on the fact that the radiation energy is accurately brought with a continuous intensity into the cornea, so that the ablation result can be obtained in the desired quality. The intensity however is influenced by reducing the laser beam produced crossing smoke clouds and tissue particle, which can lead to irregular and thus unwanted changes on the ablations. With LASIK exists the additionally danger that blown off tissue particles may settle on the flap settle, leading to its pollution and to degradation of optical quality.

U.S. Pat. No. 5,344,418 describes an implementation in which an applicator is shown close to the outlet of the laser beam with flow channels for gases and/or air, from which during the treatment a gas and/or an air flow may be directed towards the treated tissue, which has as intended consequence that the disturbing ablation residual products are blown away from the treatment area.

Hereby the problem of air pollution and the smelling nuisance for patient and operating surgeon is yet not solved.

Also, the technical solution stated in U.S. Pat. No. 5,181,916 is not able to eliminate the mentioned disadvantages. Here no gas flow is directed in the way toward the treated area to which the impurities are blown away, but the residual gases developing at the treatment place are sucked off with the help of the gas flow. An opening serves for this purpose, which is arranged concentrically around the opening by which the laser beam is withdrawn. This solution has the disadvantage that the treated visible area is only reduced during the treatment since this is partially covered by the opening.

Patent DE 100 20 522 A1 of the applicant, it known to suck off the ablation of residual products over a channel arranged over the ablation area whereby a withdrawal duct is concentrically arranged around a flushing gas feeding line at the same time. This device also covers the treatment area in this case.

This disadvantage is neither solved by patent DE 101 29 650 A1, in which a circular flow channel is radially and symmetrically arranged around the ablation area, while the gas flow on this design is steered by the discharge openings arranged on the ablation area. Thus the currents meet one another and are overlaid in such a manner that a direction reversal and thus a radially arranged outward current are produced, which tear the ablation products and the developing smoke with them. The problem of the smelling nuisance for the patient and the operating surgeon is neither solved in this case.

Departing from these antecedents, the purpose of the present invention consists of reducing the unwanted fluctuations of the laser emission intensity caused by the ablation residual products and to avoid the pollution of the environment of the ablation area.

This objective is solved according to the invention with the features of the independent patent claims, whose favorable advancements are described in the corresponding patent claims.

According to the invention, it is intended that in a configuration of the initially mentioned kind that the discharge openings are arranged in such a way that the gas flows hit symmetrically the ablation area and overlap in a resulting gas flow which is turned away from the discharge openings.

In the context of the present invention it is further appropriate, that at least one opening is intended for the resulting gas flow, which serves for the removal of the sucked off gas, which carries the residual products.

The smoke coming from the treatment place, developed during the treatment and/or from where the removed tissue particles will be collected by the gas and/or air flow, will induce itself towards the opening and will be removed from there.

Preferentially, the discharge openings are diffuser-like expanded, so that the gas with smaller flow rate can be withdrawn from these discharge openings and so an unwanted turbulence of the gas flow is avoided.

In a particularly preferred implementation of the invention, air is considered as gas and the discharge openings are connected with an air compressor or with a receiver filled with air. Favorable means should be present for the adjustment of the pressure of supplied air as well as with the flow rate at the air compressor and/or at the receiver. These means, such as pressure reducing valves, are sufficiently well-known in the state of the art and do not have to be described here in further detail. Moreover it is favorable to dampen the gas flow purposefully in order to prevent a fast draining of the tissue at the ablation area.

By overlaying the air flow in the proximity of the ablation area, the flue gas and the tissue particles are moved fast with the air flow from the location of the laser radiation and are lead afterwards, so that the energy hitting the treatment area is not impaired concerning its intensity or only in a substantially smaller extent than with the state of the art of non transparent particles.

Preferentially it is further intended that the total cross section of the discharge openings and the total cross section of the suction openings are coordinated between one another, so that the positive pressure at the discharge openings and the negative pressure at the suction openings as well as the flow rates in the discharge openings and the flow rates in the suction openings for each time unit are mostly sucked off from the amount of air around a factor, which lies between 1.1 and 1.3 times the amount of air supplied by the discharge openings.

With an implementation according to the invention, it is extremely possible that the smelling nuisance for the patient and the treating physician is avoided and the power density of laser radiation remains as far as possible even by keeping the operation area free of flue gases and/or tissue particles during the entire duration of the surgery.

In a further preferential implementation of the invention, a mechanism can be intended on one hand as an alternating disconnection of the laser radiation hitting the tissue, and on the other is intended for the air flow. This way a treatment phase will be favorably reached in each case, in which the laser radiation was directed towards the tissue and a partial ablation took place followed by a suction phase, while in the way the already described gases and/or air are supplied and/or sucked off and the ablation products are removed. At the end of this “cleaning phase”, the gas and/or air flow is interrupted and it follows a treatment phase again. It is also achieved here that the ablation products are sucked off, there is no smelling nuisance and the laser radiation is also kept free of non transparent particles, so that a radiation can meet the tissue with a continuous power density.

A particularly preferred implementation of the invention results, if in the proximity of the discharge openings and/or the suction openings are arranged infrared light sources for lighting the environment of the ablation area. With these light sources, the iris can be illuminated with the purpose of following the pupil movement, as it is described for example in U.S. Pat. No. 6,334,683, whose entire revealing is hereby referred as an example in simple way. All of this results in particularly compact units, which achieve both the distance of the residual products and make all additional light sources for the eye tracker devices redundant. Thus the structure of such treatment equipment is simplified by having fewer disturbing construction units in the field of vision of the operating surgeon.

The invention will be described in more detail below based on an example. The associated drawings show on

FIG. 1 a principle representation of the invention in a plan view, and in

FIG. 2 in a spatial perspective.

FIG. 1 shows two discharge openings 1, 2, over which the flushing gas is taken from the ablation area, as well as a suction opening 3, over which the flushing gas is extracted along with the ablation particles bound therein. The ablation area 5 of the cornea of an eye 4 is hereby represented, in which a flap 7 was cut and folded back.

The stream axles 8, 9 of the flushing rinsing gas supply cut here the not represented Z-axis of the treatment laser in the working plane of the laser treatment. This Z-axis stands perpendicularly on the reference level of FIG. 1. Both gas flows 8, 9 overlay when they meet each other and form a united current along axle 11, which is directed towards suction opening 3.

Thus results a Y-shaped arrangement of the gas openings separated between each other by the work level, whereby Y is arranged towards direction 13 of the patient's feet and the open side 12 is turned to the operating surgeon. In the preferential arrangement, a gas flow (0.5-10 m/s) is led in each case over discharge openings 1 and 2 towards eye 4. These two gas flows show the same flow rates. The discharge openings are arranged in such a way that the gas flows in ablation area 5 collide between themselves and are united in a resulting current towards suction opening 3. The resulting current is then taken up by suction opening 3.

When both air flows unite in the ablation area, they cause a particularly intensive gas throughput that leads to dragging the particles along in the current and thus to effectively removing them from the ablation area. Deposits of particles on flap 7 are prevented by the air flow direction and the intensive gas throughput. The particles that cause the smelling nuisance for both the physician and the patient are minimized this way.

In a preferential implementation the described effect is reached if the discharge openings have a diameter of 6 mm and the gas flow is led on the ablation area with a speed of 3 m/s. The negative suction pressure is coordinated in such a way that the resulting gas flow at the suction nozzle is taken up, for example with a flow rate of 3 l/S.

The angle of incidence of the gas flows in relation with the indication level is approximately in the range of 40°±15°, and the Y-angle 10 amounts to 100°±20°. The size of the angles and the arrangements of the elements ensure that the gas flows will be obstructed as little as possible by the anatomy of the head (nose, brows, etc.).

The distance between discharge openings 1, 2 and/or suction opening 3 and the ablation area 5 amounts to in the preferred implementation 75 mm±10 mm. These distances leave the treating physician with a movement clearance with an almost unhindered access to ablation area 5.

The lighting sources 6 for ablation area 5 are structurally united with discharge openings 1, 2 and suction opening 3, which are preferentially implemented as infrared light sources which serve as light sources for a camera not represented here, whose pictures can be evaluated online for the determination of the pupil location and thus the line of sight of the patient. Procedures for this evaluation are well-known by the specialists, and are not described in more detail here. As a reference, please consult U.S. Pat. No. 6,334,683.

The third infrared radiation source 6, not represented in FIG. 1, is located above suction opening 3.

The IR radiation sources are arranged between each other with an angle of 120°, whereby the infrared radiation necessary for eye tracking is not obstructed by the patient's head anatomical conditions and thus the evaluation use of the pictures taken up by the camera are significantly relieved.

By arranging the discharge openings on the physician side, on one hand make it possible to achieve the currently favorable Y-angles of 100°, and on the other hand allow the optimal angles of 120° required for the IR irradiation mechanisms.

This arrangement of the IR radiation sources and the discharge and/or suction openings provide each other simple accessibility to ablation area 5 with improved ergonomics for the operating surgeon and additionally improve the functional lighting requirements for the eye tracking device as well as reduce the distance of residual products from the ablation area.

The extraction and suction units can be easily fastened with the corresponding guides (which are not represented here), and which can be removed for cleaning or sterilizing without significant efforts.

In a further implementation, the gas flows will provide constant temperature and air humidity. That also includes a purposeful dampening of the gas flows with ultrasonic fog, in order to achieve even more constant conditions in the ablation area.

FIG. 2 shows the implementation shown in FIG. 1 in a spatial representation. The two units 14 and 15 do not include here the not visible discharge openings 1 and 2 and in each case an IR lighting source 6, which are directed towards the ablation area 5 of eye 4. Unit 16 also includes suction opening 3, and likewise an IR lighting source 6 is connected to an extraction duct 17. Angle 18 of axles 8′, 9′ and 11′ of the opposite lighting for working plane 5 amounts to 40°±15°.

Discharge openings 1, 2 and suction opening 3 are connected with pipe joints which are unions not represented here in each case, which for example are connected with a compressor or a pressurized air reservoir (concerning openings 1, 2) and/or to a suction device (concerning opening 3).

The implementation of the invention is not bound to the represented example, further expert applications do not lead to leaving the protected area. 

1-11. (canceled)
 12. A device for removing residual products from the ablation of biological tissue of a patient by laser radiation by gas flow, comprising at least two discharge openings for flows of flushing gas are arranged such that gas flows meet generally symmetrically proximate an ablation area and substantially join to form a resulting gas flow, which is extracted.
 13. A device for removing residual products according to claim 12, further comprising an extraction opening arranged such that the resulting gas flow is directed toward the extraction opening.
 14. A device for removing residual products according to claim 12, wherein in a case of two discharge openings, the two discharge openings are directed towards the ablation area at a mutual angle of about one hundred degrees plus or minus about twenty degrees.
 15. A device for removing residual products according to claim 12, wherein in a case of two discharge openings the extraction opening is arranged at an angle of about one hundred thirty degrees plus or minus about ten degrees to the discharge openings.
 16. A device for removing residual products according to claim 12, wherein the gas flows form an angle of about forty degrees plus or minus about fifteen degrees proximate the ablation area relative to an ablation plane.
 17. A device for removing residual products according to claim 12, in which the resulting gas flow is directed generally toward a body of the patient receiving treatment.
 18. A device for removing residual products according to according to claim 12, further comprising at least one lighting source located proximate one of the discharge openings and/or the extraction opening, the lighting source being directed generally toward the ablation area.
 19. A device for removing residual products according to claim 18, wherein the lighting source radiates infrared light.
 20. A device for removing residual products according to claim 18, wherein the at least one of the discharge or extraction openings is operably connected to the lighting source.
 21. A device for removing residual products according to claim 20, comprising three lighting sources and wherein the lighting sources are arranged at a mutual angle of about one hundred twenty degrees.
 22. A device for removing residual products according claim 18, wherein the lighting source serves as lighting for an eye tracking device.
 23. A method of removing residual products from the ablation of biological tissue of a patient by laser radiation, comprising: directing at least two flows of flushing gas such that gas flows meet generally symmetrically proximate an ablation area and substantially join to form a resulting gas flow; and extracting the resulting gas flow.
 24. A method of removing residual products as claimed in claim 23, further comprising arranging an extraction opening such that the resulting gas flow is directed toward the extraction opening.
 25. A method of removing residual products as claimed in claim 23, further comprising directing the gas flows towards the ablation area at a mutual angle of about one hundred degrees plus or minus about twenty degrees.
 26. A method of removing residual products as claimed in claim 23, further comprising arranging the extraction opening at an angle of about one hundred thirty degrees plus or minus about ten degrees to the discharge openings.
 27. A method of removing residual products as claimed in claim 23, further comprising arranging the gas flows such that the gas flows form an angle of about forty degrees plus or minus about fifteen degrees relative to an ablation plane proximate the ablation area.
 28. A method of removing residual products as claimed in claim 23, further comprising directing at least one lighting source generally toward the ablation area.
 29. A method of removing residual products as claimed in claim 28, further comprising operably connecting the at least one lighting source such that the lighting source is directed generally parallel to one of the flows of flushing gas or the resulting gas flow.
 30. A method of removing residual products as claimed in claim 29, further comprising directing three lighting sources and orienting the lighting sources such that they are arranged at a mutual angle of about one hundred twenty degrees. 